Services

We perform discrete tasks or lead comprehensive programs for your regulatory, quality and clinical requirements. We collaborate with your team to troubleshoot and achieve cost-effective and time-efficient solutions.

Solid Quality Systems produce superior technologies.

We provide full-service quality consulting to our clients. We support DHF activities, including development and execution of comprehensive test plans and design reviews. Our certified staff members perform multiple internal audits and supplier quality assessments each month. We regularly assist clients with FDA and State of California inspections and Notified Body audits.

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Our quality services include:

  • QMS documentation
  • QMS implementation
  • Training
  • Gap analyses
  • Supplier audits
  • Mock FDA/FDB inspections

  • Notified Body audits
  • Manufacturing/Technology transfer
  • FDA inspections
  • 483 Observation responses
  • FDB inspections

Support for major processes:

  • Management Review
  • Annual Product Review
  • Design History File
  • Device Master Test Plan
  • Design Control
  • Risk Management
  • Document Control
  • Supplier Quality
  • CAPA

  • Software Life Cycle Management
  • Software Validation
  • Complaint/MDR/Vigilance/MPR
  • Process Validation
  • Electrical safety testing
  • Sterilization Validation
  • Cleaning/Disinfection Validation
  • Packaging Validation

chief quality officer

Internal audits

  • FDA’s Quality System Regulation 21 CFR Part 820
  • EN ISO 13485
  • EN ISO 14971
  • EN IEC ISO 60601-1
  • Company’s internal SOPs and policies

  • European MDD (93/42/EEC, as amended by 2007/47/EC), IVDD or AIMD
  • Health Canada’s Medical Devices Regulations
  • Japanese Pharmaceutical Affairs Law – JPAL

QMS documentation for purchase

We offer clients a fully customized, comprehensive Quality Management System for purchase. Companies may select individual procedures such as Design Control or Risk Management, or they may opt for a complete Quality Management System that includes a Quality Manual, Standard Operating Procedures (SOPs), Department Operating Procedures (DOPs) and all relevant forms. Our documentation exemplifies best-practice methodologies and is designed in accordance with international standards and FDA requirements.

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Components of a Quality Management System

We need people who can become a part of the company in order to guide us through commercialization

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